TLC MODELS ULK-H AND ULT-H INFRARED LAMPS

K033035 · Tlc Marketing, Inc. · ILY · Nov 20, 2003 · Physical Medicine

Device Facts

• Record ID: K033035
• Device Name: TLC MODELS ULK-H AND ULT-H INFRARED LAMPS
• Applicant: Tlc Marketing, Inc.
• Product Code: ILY · Physical Medicine
• Decision Date: Nov 20, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is intended to be used for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and relaxation of muscles. In addition, the lamp may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

Device Story

TLC Infrared Lamp (Models ULK-H and ULT-H) utilizes quartz bulbs with ceramic coatings to emit infrared radiation (8-40 microns). Device provides thermal energy to target areas for temporary pain relief, increased local circulation, and muscle relaxation. Operated by users for home or clinical application. Output is infrared heat; healthcare providers or patients use the device to manage minor musculoskeletal conditions. Benefits include non-invasive symptomatic relief of pain and stiffness.

Clinical Evidence

Bench testing only.

Technological Characteristics

Infrared lamp; quartz bulbs with ceramic coatings; wavelength 8-40 microns (8,000-40,000 nanometers); two models: Whole Body (ULK-H) and Topical (ULT-H).

Indications for Use

Indicated for patients requiring temporary relief of minor muscle/joint pain, stiffness, arthritis-related joint pain, muscle spasms, sprains, strains, and minor muscular back pain; also indicated for temporary increase in local circulation and muscle relaxation.

Regulatory Classification

Identification

An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.

Special Controls

*Classification.* Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.

Predicate Devices

• Model CGO-222B TDP infrared lamp (K020851)

Submission Summary (Full Text)

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## NOV 2 0 2003 510(k) Summary

This summary of the 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the Medical Devices User Fee Act of 2002.

- 1. The sponsor of this premarket notification is:
George Works President TLC Marketing Inc. 12407 MoPac Ex. N Suite 100-413 Austin, TX 78758

- The submitter is: 2. Robert J. Mazzaferro Manager RegTech Solutions, LLC Consultant for TLC Marketing Inc. 11 Dellcastle Court Montgomery Village, MD 20886
This summary was prepared on September 29, 2003.

- The name of the device is the TLC Infrared Lamp in two models, Whole Body 3. Model ULK-H and the Topical Model ULT-H. These devices may be used for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and relaxation of muscles. In addition, the lamp may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
- The above device is substantially equivalent to the Model CGO-222B TDP 4. infrared lamp and the other models that were cleared in K020851.
- న్. The ULK-H and ULT-H lamps each contain a number of quartz bulbs with ceramic coatings that when heated emits infrared radiation with wavelengths from 8 to 40 microns (8.000 to 40.000 nanometers).
- The technological characteristics of the device are similar to those of the predicate 6. device which has a metal ceramic-coated plate which when heated emits infrared radiation with wavelengths from 1 to 25 microns (1,000 to 25,000 nanometers).

K0 33035

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol featuring three human profiles facing to the right, with flowing lines above them.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 0 2003

TLC Marketing, Inc. C/o Mr. Robert J. Mazzaferro Manager RegTech Solutions, LLC 11 Dellcastle Court Montgomery Village, Maryland 20886

Re: K033035

Trade/Device Name: TLC Models ULK-H and ULT-H Infrared Lamps Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: September 29, 2003 Received: September 29, 2003

Dear Mr. Mazzaferro:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. or 10 devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA mav publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Robert J. Mazzaferro

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

to Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 510(k) Number (if known):

Device Name: Infrared Lamp

## Indications for Use:

This device is intended to be used for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and relaxation of muscles. In addition, the lamp may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ANOTHER PAGE IF NECESSARY) Concurrence of CDRH, Office of Device Evaluation

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K633035